Z-1978-2014Class II

Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE

Name: Z-1978-2014 Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE
Creator: Stryker Howmedica Osteonics Corp.
Published: 2014-05-01
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2014-05-01 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee... on 2014-05-01. FDA classified it as Class II and gives the reason as "Tritanium Patella Inserter Instrument fracture during implantation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1978-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-01
Posted: 2014-07-02
Terminated: 2017-06-09
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using the existing Triathlon Patella Resection Guide, Metal Backed Patella Drill and Patella Peg Drill Templates as per the Triathlon Tritanium Surgical Protocol.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Tritanium Patella Inserter Instrument fracture during implantation. .
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker Orthopaedics issued an "Urgent Medical Device Recall Notification" letters/Notification Acknowledgement forms dated May 7, 2014 to their customers via Fed-Ex on May 7, 2014. The notification informs the customers of the issue(s) with the affected product; potential hazards; and how to identify and handle any affected product. Customers were instructed to return any affected product to Stryker Orthopaedics and fill out and return the enclosed Notification Acknowledgement form. For questions call (1-201-972-2100).
Quantity in commerce: 22 Units
Distribution: US Nationwide Distribution - in the states of Arizona, Florida, Kentucky, Louisiana and New Jersey.
Product codes and lots: Catalog No. 6541-3-530. Lot Codes: CTD2778 and CTD2779.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1978-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1978-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-02

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)